FDA grants Amgen gastric cancer therapy breakthrough designation

April 20, 2021

The U.S. Food and Drug Administration have awarded Amgen's bemarituzumab a Breakthrough Therapy Designation as a first-line treatment for patients with advanced gastric or gastroesophageal cancer. Amgen acquired Five Prime Therapeutics on April 16, for $1.9 billion, which included bemarituzumab.

Investigational bemarituzumab can be used as a first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.

The FIGHT trial was the first study to evaluate targeting the overexpression of FGFR2b in cancer, where bemarituzumab demonstrated clinically meaningful outcomes for patients with advanced gastric or gastroesophageal cancer as a frontline therapy. The trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b+, non-HER2 positive frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b+ tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients who showed at least 10% of tumor cells overexpressing FGFR2b.

Following sotorasib, bemarituzumab is the second asset in Amgen's oncology portfolio to receive Breakthrough Therapy Designation in the past six months.

Read the Amgen statement